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On April 19, 2024, during its 6th Public Ordinary Meeting the Collegiate Board of Directors (DICOL) of the Brazilian Food & Drug Agency (Anvisa) decided to uphold the ban on sales of Electronic Smoking Devices ("DEFs" in the Portuguese acronym) in Brazil. Formally, what Anvisa did was to officially closed its call for contributions on editing the draft rule (Public Consultation #1,222/2023) which implemented what was decided at the end of the regulatory impact analysis approved on July 6, 2023: to uphold the ban and implement additional non-normative actions aimed at reducing consumption.

The regulatory impact analysis and, consequently, Anvisa's decision in its technical aspect have received intense criticism. Such criticism, however, will not be addressed here. The topic of this article is whether Anvisa can prohibit an entire category of products, which itself describes as encompassing "numerous variations," solely based on the technical aspect related to the risks associated with their use. This question may soon be answered by Congress and/or by the Brazilian Courts.

In Congress, there are at least two bills proposing to allow the marketing of DEFs. There is Bill #3,352/2021, by Deputy Kim Kataguiri, which contains only 3 articles and is limited to classifying DEFs and synonyms for “all purposes” of cigarettes, subjecting its marketing and use to the exact same standards applied to conventional cigarettes. And there is also the bill authored by Senator Soraya Thronicke (Bill #5,008/2023) which, in its 37 articles, provides for the legal bases of a complete regulatory framework on the marketing of DEFs. But could Congress through a statute reverse Anvisa's decision in order to allow the marketing of DEFs? A look at Supreme Court case law in similar situations shows that it could.

In 2020, the Brazilian Supreme Court (STF) judged Constitutional Challenge #5501 proposed by the Brazilian Medical Association against Statute #13,269/2016, which authorized the use of synthetic phosphoethanolamine (known popularly as the “cancer pill”) by patients diagnosed with malignant neoplasia. The statute was enacted despite Anvisa having publicly and formally expressed its opposition to the use of phosphoethanolamine as medicine, given the lack of clinical studies capable of proving its efficacy and safety. The STF by majority (6 to 3)  understood that it was up to Anvisa to carry out a rigorous analysis of safety and efficacy data on any chemical substances, so that Congress could not allow the use of the substance in an abstract and generic manner, eliminating the need for Anvisa’s prior approval and, consequently, carrying out all necessary tests to prove the safety and effectiveness of the substance. The STF understood that the Congress was negligent in its duty to protect the health of the population . It is worth pointing out that, in his dissenting vote, Justice Edson Fachin recognized that Anvisa does not have exclusive authority to grant marketing authorization of any and all substances, with Congress being able to do so by statute as well. However, this rule must be detailed, in order to maintain secure the sufficient protection of the right to health.

In 2021, the STF judged Constitutional Challenge #5779, proposed by the National Confederation of Health Workers against Article 1 of Statute #13,454/2017, which authorized the marketing of anorectic substances. The statute was enacted contrary to Anvisa's decision, formalized through Rule #50/2014, which prohibited the prescription and dispensing of medicine containing this type of substances. The STF ruled Article 1st unconstitutional (score: 7 to 3) , for understanding that (i) Congress did not impose minimum care when enacting the statute to ensure sufficient protection of the right to health by ensuring the safety of the products; and (ii) the publication of the statute in the terms in which it occurred would make it impossible for Anvisa to make a technical analysis, preventing the Agency from exercising its authority, which is prohibited, as it is up to Anvisa to assess whether a given substance meets the safety, efficacy, and quality requirements.

These precedents show that the STF, for the most part, understand that Congress can act on the issue of marketing products subject to health regulation, even if it disagrees with Anvisa. What the STF clearly indicates is that there are limits to this legislative action: it cannot be insufficient in the sense of simply authorizing the marketing of the product, and must establish the necessary legal framework to ensure protection of the population's health (i.e., establish the standards for the agencies), but leaving room for Anvisa's technical action, including to complement this framework through the exercise of its normative power.

Bill #5,008/2023 fulfills this requirement perfectly well, as it deals with points relevant to the marketing, such as registration under Anvisa; specifications and prohibitions in terms of composition for each of the different types of product (with or without nicotine, with or without tobacco, for example); requirements for assessing the toxicological risk of the product, using conventional cigarettes as a parameter; advertising restrictions including requirements for packaging, with prohibitions at a high level of detail, aimed at inhibiting consumption by minors; the establishment of a pharmacovigilance system; and even tax issues. Bill #5,008 addresses all these points, but leaves room for regulation by the Brazilian Institute of Metrology, Standardization and Industrial Quality - INMETRO (for non-sanitary issues regarding the operation of devices, such as their electrical charging and battery specifications), for regulation by the Brazilian Telecommunications Agency - ANATEL (for non-sanitary issues regarding the operation of its communicability, such as via bluetooth technology), as well as for regulation by Anvisa itself.

Thus, Bill #5,008 fulfills the role required by STF’s precedents for a legitimate exercise of the law-making power, even if contrary to Anvisa's technical opinion. After all, Congress is the appropriate place for society, through its representatives, to make an informed and non-paternalized decision on the issue, considering all existing aspects (such as individual freedom in consumer decisions; the effectiveness of the current scenario in protecting users against poor quality products and preventing their use by young people; the economic impacts of fiscal nature and job creation; and the impact on public safety considering how often smuggling occurs) and not just the aspect related to safety of use; considered by Anvisa in its decision to uphold the ban.

Now, if in one hand Congress may through Bill #5,008 answer the introductory question of this article in a propositional way (structuring the legal framework for future regulation), on the other hand, the Brazilian Courts can also answer it, but in a corrective manner (by giving the debate the correct outline, removing the ban already defined by Anvisa from among the possible decisions). And in this role, the STF’s case law scenario is also positive.

A similar controversy was already brought before the Supreme Court in 2012 in the judgment of Constitutional Challenge #4874 . The Constitutional Challenge, proposed by the National Confederation of Industry, aimed to interpret Article 7, XV, of Law 9,782/1999, particularly its final section, in order to contest Anvisa's interpretation. Anvisa's assertion that it can ban goods and products arbitrarily and generally based on this provision was deemed unconstitutional. Such was the interpretation used by Anvisa to edit Rule #14/2012, through which it banned the import and sale of smoking products derived from tobacco that contained any of the flavor additives listed therein. Anvisa's interpretation and, consequently, Rule #14/2012 by itself, were not deemed unconstitutional due to a lack of necessary quorum, as there was a 5-5 tie (Justice Barroso recused himself from the case).

Among the grounds adopted by the Justices who voted in favor of the unconstitutionality is the fact that the statute that created Anvisa, Statute #9,782/99, does not have “standards” that would allow the total ban of a type of smoking products by Anvisa, treating any claim in this regard as disrespecting the principle of legality . The Justices also understood that the aforementioned Article 7, XV, when providing that Anvisa may ban “marketing of products and goods, in case of violation of relevant legislation or imminent risk to health”, must be interpreted in the sense that the section “imminent risk to health” refers to a “extraordinary, localized, concrete, and determined” risk . In other words, it does not apply to the risk ordinarily associated with products subject to control and inspection by the Agency, as is the case with smoking products. At that point, then Justice Rosa Weber, despite having voted for the constitutionality of Rule #14/2012, highlighted that the risks ordinarily associated with a given product do not attract the incidence of the hypothesis of “imminent risk to health”, intended, in fact, to deal with specific situations of an abnormal nature, as occurs when a batch of medicine with manufacturing defects is ordered to be recalled. It is true that there are no safe levels for the consumption of smoking products, and their regular consumption by itself can cause harm to health. Even so, as highlighted by Justice Alexandre de Moraes, the legislation authorizes the sale of these products, with several restrictions.

All of these grounds are relevant to the debate on the constitutionality of Anvisa's ban on DEFs. Since the ruling of Constitutional Challenge #4,874, the composition of the STF has changed, with 3 of the Justices who voted for the constitutionality of Anvisa's general and abstract ban on cigarette additives having been replaced. Of the 5 Justices who voted for the unconstitutionality of Rule #14/2012, 4 still remain in the Court. Thus, if Anvisa's decision to uphold the ban on the DEFs reaches the STF, there will be an interesting debate on the limits imposed on the Agency's actions regarding other values also constitutionally protected, such as autonomy of will (Article 5, II) and economic freedom (Article 170, sole paragraph), equality, and proportionality.